Pfizer-BioNTech Establish Lead In Coronavirus Vaccine Race, Kickstarts Regulatory Filing Process In Europe

Pfizer Inc. PFE and BioNTech SE – ADR BNTX cemented their lead in the coronavirus vaccine race by beginning the rolling submission of the regulatory application in Europe.

What Happened: The U.S.-German collaborators announced Tuesday they have initiated a rolling submission with the European Medicines Agency, or EMA, for BNT16b2, the lead candidate from their joint vaccine program.

The rolling submission allows a company to completed sections of its NDA or BLA, rather than waiting for every section to be completed before the regulatory application is filed. This will serve to expedite the review process and the review period.

"We are making every effort to develop a safe and effective vaccine following the guidance of regulatory agencies and are proud to take this historic step with the European Medicines Agency for our COVID-19 vaccine candidate, BNT162b2," said Peter Honig, SVP and Head of Worldwide Safety and Regulatory of Pfizer.

EMA's decision to allow a rolling review is hinged on positive preliminary results reported for the investigational vaccine in both preclinical and clinical studies in adults.

Data from these studies have shown BNT162b2 triggers neutralizing antibody production as well as the production of TH-1 dominant CD4+ and CD8+ T cells targeting SARS-CoV-2 that causes COVID-19.

As part of the rolling review, EMA's Committee for Medicinal Products for Human Use, or CHMP, has started evaluating data generated from preclinical trials, the companies said.

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Why It's Important: Forty-two vaccine candidates are in clinical evaluation, with five non-Chinese companies having moved their respective vaccine candidates into late-stage trials.

The initiation of rolling submission gives Pfizer/BioNTech the lead, and therefore a surefire shot at gaining the first-to-market advantage. Among others in the final lap of the race, AstraZeneca plc AZN has fallen back due to safety issues clouding its candidate. Moderna Inc MRNA has hinted at preliminary efficacy and safety data from late-stage trials coming out only in late November. Analysts see a slowdown in the enrollment rate as reasons for the drawn-out schedule.

What's Next: Pfizer and BioNTech plan to work with the CHMP to complete the review process to facilitate the final marketing authorization application.

The MAA submission, the companies said, could be finalized following the rolling review process, pending demonstration of vaccine efficacy and safety, and confirmation from the EMA that the submitted data are adequate.

"We will continue to have regular and open dialogue with the EMA throughout the rolling review process," said Ugur Sahin, CEO of BioNTech.

In pre-market trading Tuesday, Pfizer shares were adding 1.22% to $37.20 and BioNTech was advancing 9.79% to $88.60.